The FDA’s safety summary claims the extended-release formulation does not exhibit much benefit after the first day of administration.
The US Food and Drug Administration’s (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) was split 6-6 on the safety and efficacy of extended-release bupivacaine (Posimir), an investigational medicine for the treatment of post-surgical pain.
Bupivacaine is an approved anesthetic that blocks nerve impulses in the body. The new version, developed by Durect Corp., represents an extended-release formulation of the anesthetic that is administered directly into the surgical site to deliver bupivacaine for up to 3 days following surgery.
The FDA cited inconsistent results from clinical studies that do not consistently show superiority of the new extended release formulation to SABER-placebo and are inconsistent within the surgical procedures Durect planned to demonstrate efficacy in their decision.
According to the FDA, when a statistically significant treatment effect is detected in patients for pain on movement in the first 72 hours following surgery, the majority of the pain relief benefit is detected in the first 24 hours after treatment is administered.
In the FDA’s safety summary, a post hoc analysis of data submitted in the initial New Drug Application (NDA) submission is more supportive of the safety profile of SABER-bupivacaine, an extended-release depot intended to deliver bupivacaine continuously to patients for 72 hours following surgery.
There was an increased incidence in bruising, surgical site bleeding after 8 days as well as a surgical site infection in both parts of the PERSIST study and hematoma in part 2 of the study.
There was also an increased incidence in somnolence, headache, pruritus, and dysgeusia in both parts of the study and dizziness in the first part of the study.